Improving Mood for Adolescents Through Teaming With End-Users in Routine Care (The iMATTER Project)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-17
SponsorChildren's Hospital of Philadelphia

About this trial

This pilot randomized controlled trial will examine the feasibility, acceptability and preliminary efficacy of an adolescent depression prevention program, Brief Interpersonal Psychotherapy-Adolescent Skills Training (B-IPT-AST), in primary care.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adolescents ages 13 to 17 years.

Adolescents must be English-speaking.

Legal guardian permission (informed consent) and child consent/assent.

A score of 5-10 on the Patient Health Questionnaire 9-Item: Modified for Teens (PHQ-9-M) at the primary care well-visit.

Disqualifiers

Suicidal ideation or behaviors reported on the PHQ-9-M at their well-visit (score of 1 or higher on item 9 "In the past week, have you had thoughts that you would be better off dead, or of hurting yourself in some way?" and/or yes to either of the supplemental questions which ask, "Has there been a time in the past month when you have had serious thoughts about ending your life?" and "Have you ever, in your whole life, tried to kill yourself or made a suicide attempt?") based on medical record review. For the PHQ-9-M administered at baseline, adolescents who mark yes to the supplemental item about serious suicidal ideation in the past month ("Has there been a time in the past month when you have had serious thoughts about ending your life?") will be excluded.

Major medical illness, significant behavioral problems or intellectual or developmental disabilities that may interfere with the completion of all study procedures.

Youth may be excluded on a case-by-case basis if the EHR review, eligibility screener, baseline evaluation, or other interactions with the family suggests that the group program would not be appropriate.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Brief Interpersonal Psychotherapy - Adolescent Skills Training (B-IPT-AST)

    Behavioral

    This is an adolescent depression prevention program consisting of 6 sessions (4 group and 2 individual sessions).

  • Services as usual (SAU)

    Behavioral

    Services as usual (SAU) involves any mental health services adolescents decide to receive in primary care or in the community. It is possible that adolescents in SAU may decide not to participate in any mental health services.

Treatment groups

45 Participants
are divided into 2 treatment groups
Group A: Brief Interpersonal Psychotherapy-Adolescent Skills Training (B-IPT-AST)Experimental treatment 1 intervention
Group B: Services as usual (SAU)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Acceptability: A self-report measure, the Attitude Towards Intervention Questionnaire (ATI)

A self-report measure, the Attitude Towards Intervention Questionnaire (ATI), will be completed by adolescents to assess acceptability of Brief Interpersonal Psychotherapy-Adolescent Skills Training (B-IPT-AST) following the intervention. The ATI includes 11 Likert scale items and one open-ended item for providing additional feedback. Likert scales vary by item but are generally 3- or 5-point scales (e.g., very helpful to very unhelpful). Each item is interpreted on its own (e.g., the percentage of teens who found B-IPT-AST very or a little helpful)

Time frame
0-6 Weeks Post-Intervention
2

Attendance

The number of individual and group B-IPT-AST sessions that teens attend will be tracked in order to report on the average number of group sessions attended (out of 4) for the total sample as well as the average number of individual sessions (out of 2) attended across the sample

Time frame
Weekly during B-IPT-AST
3

Retention

To gauge feasibility, retention will be assessed by comparing the number of families who remain in the study through post-intervention to the number who consented.

Time frame
Baseline, 0-6 Weeks Post-Intervention
4

Depression symptoms

Change in depression symptoms will be measured by the Center for Epidemiologic Studies-Depression Scale (CES-D) which assesses the frequency of 20 depressive symptoms over the past week; CES-D scores range from 0 to 60 (scores of 16 or higher are considered elevated); higher scores indicate more depression symptoms

Time frame
Baseline, 0-6 Weeks Post-Intervention

Secondary outcomes

1

Internalizing and externalizing symptoms

Changes in internalizing and externalizing symptoms will be assessed by the Pediatric Symptom Checklist (PSC-17), which will be completed by teens and caregivers; there is a total score (range of 0-34), internalizing subscale (0-24), externalizing subscale (0-20), and attention problems subscale (0-24); higher scores indicate more symptoms

Time frame
Baseline, 0-6 Weeks Post-Intervention
2

Impairment (Child Report)

Change in impairment will be measured via teen report on the Columbia Impairment Scale (CIS), 13-item scale of overall functioning; scores range from 0-52; a score of 15 or higher is considered elevated impairment; higher scores represent greater impairment

Time frame
Baseline, 0-6 Weeks Post-Intervention
3

Impairment (Parent Report)

Change in impairment will be measured via parent report on the Columbia Impairment Scale (CIS), 13-item scale of overall functioning; scores range from 0-52; a score of 15 or higher is considered elevated impairment; higher scores represent greater impairment

Time frame
Baseline, 0-6 Weeks Post-Intervention
4

Perspective-taking

Changes in perspective taking will be measured by the Interpersonal Reactivity Index (IRI), a 7-item perspective-taking scale; scores range from 0-28 with higher scores representing more perspective taking

Time frame
Baseline, 0-6 Weeks Post-Intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Children's Hospital of Philadelphia

Lead sponsor

The Klingenstein Third Generation Foundation

Collaborator